Validation, Disposition and Change Control

A colleague asks “How do you manage changes and disposition when doing lon-term validation or specification setting in multiple markets?”

Process map for change control, validation, regulatory and disposition

Perhaps it is a cleaning validation, or a major process change, or a new filter or raw material. You need to be able to disposition product against a change control to some markets but not all.

It is important to realize that changes become effective at multiple times. Looking back on the post “Changes become Effective” we are managing after change-in-use where the regulatory approval is not being simultaneously gated and product will be sent to market on a case-by-case basis.

The change control contains a corresponding regulatory assessment with required variations for all impacted markets, and a disposition strategy aligned with validation activities. With action items (e.g. work, tasks) in the change control for ongoing evaluation of lots impacted by study.

That disposition strategy might include evaluation of data vs acceptance criteria for each lot via checklist (or other tool) included in disposition packet; or an evaluation of data through change control task and disposition references change control. They are pretty similar in results and it more ends up being a record management preference.

High level match between regulatory and inventory

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